MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø12X360MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85202360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported: "a patient presented with increasing pain at the hip consistent with non-union on x-rays the removal of painful hardware (gamma-4) yesterday, non-union bone repair and ultimately fixation with a non-stryker nail".Additional information indicates nail breakage is present.
Event or Problem Description
It was reported: "a patient presented with increasing pain at the hip consistent with non-union on x-rays the removal of painful hardware (gamma-4) yesterday, non-union bone repair and ultimately fixation with a non-stryker nail".Additional information indicates nail breakage is present.
Additional Manufacturer Narrative
Correction: please refer to h6 results code.The reported event could be confirmed, since the breakage of the nail in combination with a non-union can be confirmed based on the review of the received x-rays and operation report.The devices were not returned for evaluation and therefore no further evaluation is possible.A review of the device history was not possible because the lot number was not communicated.No corrective actions are currently required.A review of the labeling did not indicate and abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.The complaint was forwarded to medical affairs for review with the following results: ¿first of all, we have limited information here.We only have the x-rays after the breakage of the nail.Interesting case.Clearly there was a non-union or delayed union at 6 months.In a united bone the nail would not break anymore.There are some interesting observations to be seen on these x-rays.Distally, the screw seems to be quite short, and the question arises whether it ever was long enough to penetrate the second cortex properly.It is quite clear the screw backed out and that already happened quite a while ago since there is a bump of callous formation around the head of the screw.The backing out of the screw can be explained if the screw indeed was too short and di not have sufficient hold in the second cortex.The backing out led to movement in the nail since it lost its distal stability.Proximally, the current x-rays suggest this was a sub trochanteric fracture, which needs more stability in the implant than a per trochanteric one with more intrinsic stability.If the distal stability is lost, movement of the nail will have influence on the fracture area and thus the lag screw nail interface.The lag screw is not entirely in the ideal position, which may or may not have had additional influence on the movement in the fracture site, leading to a non-union and subsequent nail breakage.Based on the provided information, the root cause is multi-factorial.The location of the fracture and the technical aspects of the surgical procedure contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø12X360MM X 120°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19181965
• Report Number: 0009610622-2024-00167
• Device Sequence Number: 12570791
• Product Code: HSB
• UDI-Device Identifier: 07613327477238
• UDI-Public: 07613327477238
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 85202360S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 128 KG